The Pfizer-BioNTech coronavirus vaccine appears poised to become available to children 5 to 11 years old within weeks, after a Food and Drug Administration review found the benefits of the shot outweigh the risks in most scenarios, with the possible exception of when there are very low levels of viral transmission.
The review found that for four scenarios that were weighed, “the benefits of the Pfizer-BioNTech COVID-19 Vaccine 2-dose primary series clearly outweigh the risks.” But in one, when the virus was at its lowest levels, there could be more hospitalizations related to a rare heart side effect associated with the vaccine than the number of hospitalizations prevented from COVID-19, the illness caused by the virus.
Even then, the review found, “the overall benefits of the vaccine may still outweigh the risks under this lowest incidence scenario” because of how hospitalized cases of the two conditions differ. The vaccine-related myocarditis cases have tended to resolve in a few days, unlike COVID-19 infections, which can lead to death.
Pfizer said vaccine was over 90 percent effective in children.
The review represents the first independent evaluation of company data and arrives ahead of a pivotal meeting next week at which outside experts are scheduled to debate and vote on whether the vaccine should be authorized. Extending vaccine eligibility to children younger than 12 has been a major goal of public health officials and eagerly awaited by many pediatricians and families.
Pfizer and its German partner BioNTech reported in a separate document posted Friday that their coronavirus vaccine is 91 percent effective in 5- to 11-year-olds.